Hematology control or calibrator with red cell components of enhanced stability

• US 4,777,139 A
• Filed: 06/25/1987
• Issued: 10/11/1988
• Est. Priority Date: 06/25/1987
• Status: Expired due to Fees

• Current Assignee: Il Holding SpA (Werfen SA)
• Original Assignee: Fisher Scientific Co. (Thermo Fisher Scientific Incorporated)
• Inventors: Wong, Show-Chu, Deol, Harbans S., Davidson, Jill H., Harz, Debra L.
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US07/066,265
• Time in Patent Office: 474 Days
• Field of Search: 436/8-18, 424/3, 422/61, 422/73, 252/408.1
• US Class Current: 436/18
• CPC Class Codes: G01N 2496/05 containing blood cells or plasma
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

Red cells are exposed to an unsaturated aldehyde such as acrolein (propenal) under conditions sufficient to increase the stability of the cells without impairing the ability of a lysing reagent to lyse the cells. After treatment, the treated cells are washed and are suspended in a stabilizing suspension medium.

Claims

1. A hematology control or calibrator comprising a suspension of treated erythrocytes in a stabilizing medium, characterized by the treated erythrocytes having been exposed to a aliphatic unsaturated aldehyde of 3-6 carbons under conditions sufficient to increase the stability of the treated erythrocytes in the stabilizing medium without impairing the ability of a lysing reagent to lyse the treated erythrocytes in a hematology analyzer.

2. The hematology control or calibrator of claim 1 wherein the aliphatic unsaturated aldehyde is propenal.

3. The hematology control or calibrator of claim 2 wherein the treated erythrocytes have been exposed to propenal at a concentration of about 0.01% to about 1.0% for a time of about 5 minutes to about 24 hours at a temperature from about 0°

C. to about 30°

C.

4. The hematology control or calibrator of claim 3 wherein the temperature is about 20°

-25°

C., the time is about 1 to 4 hours and the concentration is about 0.02-0.2%.

5. The hematology control or calibrator of claim 3 wherein the temperature is about 0°

-5°

C., the time is about 15-30 hours and the concentration is about 0.02-0.2%.

6. A process for preparing a hematology control or calibrator comprising the steps:

(a) exposing washed erythrocytes to an unsaturated aldehyde at a treatment concentration and temperature for a treatment time period,

(b) after the treatment time period, washing the treated erythrocytes, and

(c) suspending the treated and washed erythrocytes in a stabilizing suspending medium the treatment concentration, temperature and time being sufficient to increase the stability of the treated erythrocytes in suspending medium without impairing the ability of a lysing reagent to lyse the treated erythrocytes in a hematology analyzer.

7. The process of claim 6 wherein the aliphatic unsaturated aldehyde is propenal.

8. The process of claim 7 wherein the treatment concentration is about 0.01% to about 0.5%, the treatment temperature is about 0°

C. to about 30°

C. and the treatment time is about 5 minutes to about 24 hours.

9. The process of claim 8 wherein the treatment concentration is about 0.02 to about 0.2%, the treatment temperature is about 20°

C. to about 25°

C. and the treatment time is about 1 to 4 hours.

10. The process of claim 8 wherein the treatment concentration is about 0.02% to about 0.2%, the treatment temperature is about 0°

C. to about 5°

C. and the treatment time is about 15-30 hours.